Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing performance and review of proficiency testing evaluation reports from the proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing provider, American Proficiency Institute, the laboratory failed to achieve satisfactory performance scores for the Compatibility Testing proficiency testing for two consecutive proficiency testing events, (event 1 in 2025 and event 2 in 2025), see D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS-155 Proficiency Testing (PT) scores report from the American Proficiency Institute (API) and a review of the evaluation report provided by the PT provider, the laboratory failed to achieve a score of 100% for Compatibility Testing for event 1 in 2025, and event 2 in 2025. Findings: 1. A review of the CMS- 155 Individual Laboratory Profile on 10/09/2025, at 11:15 AM, revealed the Compatibility Testing score for PT event 1 in 2025 was 80%, and the testing scores for event 2 in 2025 was 80%. 2. A review of the evaluation report provided by the PT provider on 10/09/2025, at 11:30 AM, confirmed the Compatibility Testing score for PT event 1 in 2025 was 80%, and the testing scores for event 2 in 2025 was 80%. -- 2 of 2 --